The bacterium Borrelia burgdorferi (sensu lato) is the causative agent of Lyme borreliosis, i.e., Lyme disease. This illness is caused by transmission of the spirochetes by the bite of various species of Ixodes ticks. The main reservoir of the infection in the United States is the white footed mouse, Peromyscus leucopus, and the infection can be transmitted to many mammalian species including dogs, cats and man [J. G. Donahue, et al., Am. J. Trop. Med. Hyg., 36:92-96 (1987); R. T. Green, et al, J. Clin. Micro., 26:648-653 (1988)]. In addition, the disease may persist for years despite an active immune response and such persistence is postulated to be the result, at least in part, of antigenic variation in the bacterial proteins [J. R. Zhang, et al., Cell, 89:275-285 (1997)].
There have been numerous publications relating to proteins and polypeptides of Borrelia burgdorferi and their potential use as diagnostic or pharmaceutical agents, but the vast majority have focused on the humoral immune response during human infection. The result has been widespread availability of accurate serodiagnostic tests for confirming the illness in humans [See, for example, Aguero-Rosenfeld, et al., Diagnosis of Lyme Borreliosis, Clinical Microbiology Reviews, July 2005, p. 484-509 and references contained therein]. However, the humoral immune responses during canine Lyme disease have not to date been studied extensively. Rather, serodiagnostic tests developed for human use have been used interchangeably in canines and the result has been considerable confusion caused primarily by inaccuracy of test results. Researchers [Lovrich, S. D., et al., Clinical and Vaccine Immunology, 14:635-637, 2007] recently provided explanation for the confusion by confirming significant differences in the specificities of the antibody responses that occur during human or canine Lyme disease. In fact, only one test developed originally for confirming human Lyme disease, detecting antibodies to the C6 peptide, has been proven useful for confirming the illness in dogs [Levy, S A, et al., Veterinary Therapeutics, 3:308-315, 2002] and the procedure is now considered the gold standard. However, response to C6 is often not detectable until several weeks or months after infection. Therefore, there exists a clear need in the art for a simple, sensitive and specific diagnostic composition and method, especially for early detection of Lyme disease in canines.